Investigation of the Ringer Perfusion Balloon Catheter (Ringer PTCA)
Study Details
Study Description
Brief Summary
The objective of this study is to demonstrate safe and effective use of the Ringer perfusion balloon catheter for dilatation/pre-dilatation of coronary stenoses during percutaneous coronary intervention (PCI).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
A prospective, multicenter, single-arm clinical study. The study will be conducted in 3 to 5 investigational sites in the US and Canada and will enroll up to 60 participants. The population for this study is adult participants undergoing non-emergent percutaneous coronary intervention (PCI) as a stand-alone procedure or following non-emergent diagnostic angiography performed during the same procedure.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Adult subjects clinically indicated for non-emergent percutaneous coronary intervention (PCI) as a stand-alone procedure or following non-emergent diagnostic angiography performed during the same procedure that, in the physician's estimation, requires prolonged balloon inflation with distal perfusion. |
Device: Ringer Perfusion Balloon Catheter
Non-emergent Percutaneous Coronary Intervention (PCI) for treatment of a coronary artery lesion with Ringer Perfusion Balloon Catheter.
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Outcome Measures
Primary Outcome Measures
- Effectiveness of device success in dilatation/pre-dilatation of coronary stenosis during PCI. [During Procedure]
Successful delivery, inflation, deflation and withdrawal of the Ringer device; final thrombolysis in myocardial infarction (TIMI) flow grade of 3 at the conclusion of the PCI procedure.
- Rate of clinically relevant events [Discharge or 30 days, whichever comes first]
Rate of Ringer related complications arising during delivery, inflation or removal of Ringer; freedom from major cardiac adverse events (MACE)
Secondary Outcome Measures
- Successful PCI [During Procedure]
Final residual stenosis ≤20% diameter stenosis (in-stent) or ≤50% diameter stenosis (stand-alone balloon) by visual angiographic estimation and freedom from MACE.
- TIMI Flow [During Procedure]
Maintenance of TIMI-2 or -3 flow into distal coronary bed during Ringer inflation
- Ringer Inflation [During Procedure]
Tolerance of at least one Ringer inflation greater than one minute (prolonged inflation) at target site (measured with symptoms, ECG, hemodynamics).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male and Female subjects >18 years old.
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Patients undergoing clinically indicated non-emergent PCI as a stand-alone procedure or in combination with diagnostic angiography during the same procedure.
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Study target lesion characteristics: a) native de-novo coronary stenosis of at least 70% visually estimated stenosis, or at least 50% visually estimated stenosis and shown to be physiologically significant by flow-mediated criteria (FFR <0.80, IFR <0.91); b) estimated reference vessel diameter 2.0-4.5mm; c) lesion length <25mm; d) calcification not greater than mild.
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Per investigator assessment, the patient may benefit from inflation distal perfusion during balloon inflation. Examples include, but are not limited to: (i) LV systolic dysfunction with LVEF<50% by any modality; (ii) a territory subtended by the target vessel downstream from the target lesion that is estimated to be in excess of 25% of viable LV mass; (iii) prior hemodynamic or electrical instablility during intervention on the target lesion; (iv) the potential to avoid placement of a coronary stent if a stent-like result can be achieved through prolonged balloon inflation.
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Female subjects of childbearing potential must have a negative pregnancy test per standard of care for PCI and be practicing contraception.
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Informed consent provided.
Exclusion Criteria:
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Hemodynamic or arrhythmic instability within 48 hours or a myocardial infarction within 72 hours of PCI.
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More than 2 lesions planned during index PCI.
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Procedural complication developing prior to PCI of study target.
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Ejection fraction (EF) <25%.
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Creatinine clearance (Cr-Cl) <25 mg/dL.
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Baseline flow at study target <TIMI-2.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brigham & Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 2 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 3 | University of Washington Medical Center | Seattle | Washington | United States | 98196 |
| 4 | Heart Health Institute | Scarborough | Ontario | Canada | M1B 4Z8 |
| 5 | Sunnybrook Heath Sciences Center | Toronto | Ontario | Canada | M4N3M5 |
| 6 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
Sponsors and Collaborators
- Vascular Solutions LLC
Investigators
- Study Director: Ridardo DeMedeiros, PhD, Teleflex
- Principal Investigator: Kathleen Kearney, MD, University of Washington
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ST3170